SepsisNCT03796715
Red Cell Distribution Width Versus Presepsin (Soluble CD14) as a Prognostic Marker in Critically-ill Sepsis Patients
An observational study of Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels correlates well with sepsis severity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Red Cell Distribution Width (RDW) and Presepsin (sCD14-ST)
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 24 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the general ICU with sepsis or septic shock of both sexes between 18 and 65 years of age.
Who may be able to join
- Male or female aged 18 65 years.
- Appropriate clinical data to enable classification into sepsis or SIRS according to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
- Written informed consent by the patient or guardian
Who cannot join
- No informed consent
- Renal failure
- Liver failure
- Hematologic diseases
- Neutropenia
- Malignancy
- Chemotherapy during the previous 90 days.
- Patients using antibiotics at presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Red Cell Distribution Width Versus Presepsin (Soluble CD14) for Prognosis Assessment in Sepsis Patients Admitted to the Intensive Care Unit
Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels correlates well with sepsis severity. Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population. we aim to compare between Presepsin (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.
- Conditions
- Sepsis
- Being tested
- Red Cell Distribution Width (RDW), Presepsin (sCD14-ST)
- Keywords
- sepsis, presepsin, red cell distribution width
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Cell Distribution Width (RDW)Diagnostic test
A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker.
Presepsin (sCD14-ST)Diagnostic test
: A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker.
| Study group | Role | What they receive |
|---|---|---|
| Red Cell Distribution Width (RDW) | RDW was assessed as part of complete blood count analysis using SYSMEX XN-550 automated analyzer Receives: Diagnostic Test: Red Cell Distribution Width (RDW) | |
| Presepsin (sCD14-ST) | Presepsin analysis was done by utilising Elisa technique using kits from (MyBioSource, San Diego, CA 92195-3308 USA) Receives: Diagnostic Test: Presepsin (sCD14-ST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality during intensive care unit stay
Measured: 28 days
Secondary outcomes (6)
Length of ICU stay
Measured: assessed up to 3 months
Need for readmission to ICU
Measured: assessed up to 3 months
Ventilatory support duration
Measured: assessed up to 3 months
Number of participants who need renal replacement therapy
Measured: assessed up to 3 months
Number of participants who need inotropic or vasopressor support
Measured: assessed up to 3 months
Transfusion requirements (blood and blood products)
Measured: assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Aug 2018
- Primary completion20 Nov 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed, Ain Shams University
- Investigators
- Ahmed Elsayed, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796715
- Sponsor's protocol ID
- FMASU R76/2018
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Red Cell Distribution Width Versus Presepsin (Soluble CD14) for Prognosis Assessment in Sepsis Patients Admitted to the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03796715
- Acronym / sponsor ID
- FMASU R76/2018
- Conditions
- Sepsis
- Keywords
- sepsis, presepsin, red cell distribution width
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels correlates well with sepsis severity. Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population. we aim to compare between Presepsin (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Cell Distribution Width (RDW) | – | Diagnostic Test: Red Cell Distribution Width (RDW)RDW was assessed as part of complete blood count analysis using SYSMEX XN-550 automated analyzer |
| Presepsin (sCD14-ST) | – | Diagnostic Test: Presepsin (sCD14-ST)Presepsin analysis was done by utilising Elisa technique using kits from (MyBioSource, San Diego, CA 92195-3308 USA) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the general ICU with sepsis or septic shock of both sexes between 18 and 65 years of age.
Key inclusion criteria (3 listed)
- Male or female aged 18 65 years.
- Appropriate clinical data to enable classification into sepsis or SIRS according to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
- Written informed consent by the patient or guardian
Key exclusion criteria (8 listed)
- No informed consent
- Renal failure
- Liver failure
- Hematologic diseases
- Neutropenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Cell Distribution Width (RDW)A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker. | Diagnostic test | Red Cell Distribution Width (RDW) |
| Presepsin (sCD14-ST): A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker. | Diagnostic test | Presepsin (sCD14-ST) |
Primary outcome
Mortality during intensive care unit stay
Time frame: 28 days
6 secondary outcomes
Length of ICU stay
Time frame: assessed up to 3 months
Need for readmission to ICU
Time frame: assessed up to 3 months
Ventilatory support duration
Time frame: assessed up to 3 months
Number of participants who need renal replacement therapy
Time frame: assessed up to 3 months
Number of participants who need inotropic or vasopressor support
Time frame: assessed up to 3 months
Transfusion requirements (blood and blood products)
Time frame: assessed up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elsayed principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality during intensive care unit stay (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.